Method Development Scientist - Principal Investigator (PI)/Project Manager (LC-MS/MS)
- - Small Molecule
- Indianapolis, IN, USA
- Full Time
Opportunity for a skilled bioanalytical scientist to join an exciting, growing contract research organization!
AIT Bioscience (AITB) is a leading bioanalytical services contract research organization (CRO), serving the pharmaceutical, biotech, and animal health industries. LC-MS/MS and multiple large molecule platforms combine to provide regulatory compliant bioassay support development of new medicines from Discovery to Pre-Clinical and Clinical through Commercialization.
AITB is the first and only CRO in the world to provide solutions for all molecule types (large, small, and peptides/biomarkers) in a purpose-built facility utilizing a fully electronic analytical lab notebook system. With our customized, real-time QC system, quality has literally been built into everything we do and everywhere we do it. Bioanalytical capabilities and expertise support both stand-alone projects and full IND/NDA enabling programs, allowing AITB to support its clients with a hands-on approach, scientific collaboration, high quality, and on-time delivery.
Due to our continued growth, AITB is seeking an experienced Bioanalytical Method Development Scientist/Principal Investigator/Project Manager with expertise in LC-MS/MS bioanalysis for our Indianapolis laboratory. The Principal Investigator is primarily responsible for small molecule and biomarker method development and validation studies.
Summary of Job Responsibilities
• Serves as a Responsible Scientist or Principal Investigator (PI) for non-regulated and GLP-regulated assay development and validation studies.
• Ensures client small molecule, biomarker, LC-MS/MS programs meet AIT Bioscience, sponsor, and regulatory requirements.
• Serves as the scientific point of contact for the sponsor.
• Develops method development and validation experiments for execution
• Independently performs analysis, interpretation and develops conclusions from analytical data. Reviews and approves raw data.
• Reviews data to ensure methods are ready for validation. Approves validation methods and reviews sample analysis methods.
• Depending on workload, continues laboratory work through to sample analysis, as applicable
• Reviews and approves reports for scientific accuracy and completeness.
• Takes accountability and demonstrates responsibility regarding scientific study conduct.
• Actively promotes collaboration within and across groups.
• Provides appropriate coaching and recognition to team members.
• Promotes a positive impression of AIT Bioscience internally and within the industry.
• Plans, prioritizes, and manages workload for large and complex projects.
• Assists in business development activities.
Education / Qualifications
• BSc, MS, PhD or equivalent in Analytical Chemistry, Chemistry, Biochemistry or a closely related field.
• Experience conducting method development, validation and analysis to support toxicokinetic, pharmacokinetic (TK/PK) assays and biomarker assays in a pharmaceutical or contract research organization (CRO) environment under FDA/EMA regulations
• Demonstrated mathematical, reasoning and computer skills to apply principles of logical and scientific thinking and performance to a wide range of bioanalytical projects.
• 5+ years of assay development experience. This means you can take a structure and then develop, optimize and validate an assay from scratch.
• 3+ years as a Principal Investigator (PI) in a GLP compliant lab.
• Knowledge of global regulatory bioanalytical agency guidelines.
• Operate, calibrate and maintain laboratory equipment and analytical instruments
• Experience with Thermo LC-MS/MS platform preferred.
• Experience with Watson® LIMS preferred.
• Excellent communication and interpersonal skills.
• Proven ability to prioritize and manage time.
• Excellent attention to detail.
• Able to utilize word processing, database, spreadsheet, and specialized software.
Due to the unique systems employed by AIT Bioscience, this person must also have a high level of competency in computer systems and be comfortable with the concept and practice of operating in a paperless environment. The department has been an early adopter in the use of electronic laboratory note books for regulated bioanalysis.
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